The Italian Medicines Agency AIFA provides some clarifications to all pharmaceutical companies regarding the submission of changes to the AIC. These clarifications concern the changes presented according to the national, mutual recognition/decentralized (MR/DC) procedure pursuant to EC Regulation No. 712/2012 and in line with the new “classification guidelines” of the European Commission dated 16/05/2013. The objective is to favor the correct presentation by companies of applications concerning changes to the AIC. You can find enclosed the update of the Explanatory Note of the AIFA Resolution of 25 August 2011.
_{August 4, 2021}

The European Medicines Agency issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission GMP guidelines and other EU legislation. In general, these responsibilities range from responsibilities that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks. These responsibilities are spread over the various chapters and annexes of the GMP Guide, and are quite numerous.
_{August 2, 2021}